Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product description
Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lot numbers, UPCs & expiration codes
All lots distributed between November 2014 and May 2015; 04102015@70, 7/9/2015; 04212015@9, 7/20/2015; 04092015@75, 7/8/2015; 03022015@1, 5/31/2015; 04202015@12, 7/19/2015; 03112015@19, 6/9/2015; 03032015@36, 6/1/2015; 03032015@40, 6/1/2015; 03062015@28, 6/4/2015; 03192015@5, 6/17/2015; 03202015@15, 6/18/2015; 03172015@18, 6/15/2015; 03172015@27, 7/13/2015; 03202015@87, 6/18/2015; 03242015@35, 6/22/2015; 05042015@76, 8/2/2015; 03272015@9, 6/25/2015; 03312015@14, 6/29/2015; 03272015@33, 6/25/2015; 03272015@43, 6/25/2015; 04012015@37, 6/30/2015; 04022015@32, 7/1/2015; 04162015@39, 7/15/2015; 04232015@5, 7/22/2015; 04212015@65, 7/20/2015; 04222015@48, 7/21/2015; 04272015@65, 7/26/2015; 05052015@96, 8/3/2015; 05012015@34, 7/30/2015; 05052015@87, 8/3/2015; 05072015@53, 8/5/2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1723-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 2, 2015
- FDA report date
- Sep 23, 2015
- Quantity
- 3215 ml
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Compounding Pharmacy of America
Original FDA data
Every field from FDA enforcement report D-1723-2015, exactly as published.
Show all FDA fields
- City
- Knoxville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 71371
- Address
- 6216 Highland Place Way Ste 101-A
- Code information
- All lots distributed between November 2014 and May 2015; 04102015@70, 7/9/2015; 04212015@9, 7/20/2015; 04092015@75, 7/8/2015; 03022015@1, 5/31/2015; 04202015@12, 7/19/2015; 03112015@19, 6/9/2015; 03032015@36, 6/1/2015; 03032015@40, 6/1/2015; 03062015@28, 6/4/2015; 03192015@5, 6/17/2015; 03202015@15, 6/18/2015; 03172015@18, 6/15/2015; 03172015@27, 7/13/2015; 03202015@87, 6/18/2015; 03242015@35, 6/22/2015; 05042015@76, 8/2/2015; 03272015@9, 6/25/2015; 03312015@14, 6/29/2015; 03272015@33, 6/25/2015; 03272015@43, 6/25/2015; 04012015@37, 6/30/2015; 04022015@32, 7/1/2015; 04162015@39, 7/15/2015; 04232015@5, 7/22/2015; 04212015@65, 7/20/2015; 04222015@48, 7/21/2015; 04272015@65, 7/26/2015; 05052015@96, 8/3/2015; 05012015@34, 7/30/2015; 05052015@87, 8/3/2015; 05072015@53, 8/5/2015
- Postal code
- 37919-4068
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-1723-2015
- Classification
- Class II
- Recalling firm
- The Compounding Pharmacy of America
- Product quantity
- 3215 ml
- Termination date
- Feb 10, 2016
- Reason for recall
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 2, 2015
- Initial firm notification
- Telephone
- Center classification date
- Sep 15, 2015